Does the frequency and mode of surveillance affect patient survival following extremity STS surgery?
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue neoplasms
- Soft tissue neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome for the definitive trial will be overall five-year
survival. The primary outcome measure will be death from any cause.
Secondary outcome
Patient Anxiety Outcome Measure: The validated Patient-Reported Outcomes
Measurement Information System (PROMIS)® Cancer-Anxiety questionnaire will be
used to assess patient anxiety. This questionnaire will be administered at the
baseline visit, as well as the 6-month, 12-month, 18-month and 24-month
intervention phase and 36-month, 48-month and 60-month post-intervention phase
visits.
Patient Overall Satisfaction Outcome Measure: The validated PROMIS®
Satisfaction with Social Roles and Activities questionnaire will be used to
assess patient overall satisfaction. This questionnaire will be administered at
the baseline visit, as well as the 6-month, 12-month, 18-month and 24-month
intervention phase and 36-month, 48-month and 60-month post-intervention phase
visits.
Quality of Life Outcome Measure: The validated EuroQol-5 Dimension (EQ-5D) will
be used to assess patient quality of life. This questionnaire will be
administered at the baseline visit, as well as the 6-month, 12-month, 18-month
and 24-month intervention phase and 36-month, 48-month and 60-month
post-intervention phase visits.
Local Recurrence-Free Survival (LRFS) Outcome Measure: LRFS will be defined as
the length of time from the time of randomization that the participant survives
with no detection of recurrent disease at the initial tumor site or operative
field. Local disease recurrence and the modality in which it was identified
(i.e. physical exam, MRI, ultrasound) will be documented on participant case
report forms (CRFs).
Metastasis-Free Survival (MFS) Outcome Measure: MFS will be defined as the
length of time from the time of randomization that the participant survives
with no detection of systemic disease recurrence at any anatomic location.
Systemic disease recurrence and the modality in which it was identified (CXR,
CT, PET scan, bone scan) will be documented on participant CRFs.
Treatment-Related Complications Outcome Measures: Treatment-related
complications will include both chemotherapy-related complications, such as
febrile neutropenia, fungal infections or sepsis, and thoracotomy-related
complications, such as pneumothorax or surgical site infections. All
treatment-related complications will be documented on participant CRFs.
Net Healthcare Costs Outcome Measures: We will perform an incremental cost
analysis of net costs of surveillance and costs incurred from metastasis
treatment and metastasis treatment-related complications. Data will be
documented on participant CRFs at each outpatient visit and hospital admission.
The direct costs will include physician billing for clinic visits, per unit
cost of CXR and CT scans, systemic therapy costs, hospital admission costs
related to systemic therapy complications, thoracotomy costs and hospital
admission costs for complications related to thoracic surgical intervention.
Unit costs for all resources used by trial participants will be obtained from
regional statistics and from clinical sites participating in the trial. These
unit costs will be combined with the resource volumes to obtain a net cost per
participant over their time in the trial.
Background summary
Following treatment for a soft tissue sarcoma (STS) that is not metastatic at
presentation, the risk for local and systemic disease recurrence necessitates
careful post-operative surveillance. Between 40 and 50% of all sarcoma patients
will develop a local or distant recurrence; however, the risk of recurrence is
greatest in the first few years, with 68% occurring by two years and 90% by
five years. Metastasis to the lung is the most frequent single location of
disease recurrence in sarcoma patients, occurring in the majority of patients
with metastases. Therefore, routine follow-up after completing sarcoma
treatment is standard practice, and generally entails regular visits to sarcoma
outpatient clinics in the first five years after surgery. These visits
typically include a clinical history, physical examination and imaging of the
lungs (chest radiograph [CXR], or computed tomography [CT] scan of the lungs).
Earlier detection of less advanced and resectable disease recurrence may
prolong patient survival. However, once advanced metastases are detected, the
median length of survival is 12 to 15 months and systemic chemotherapy has
little impact on overall survival. Based on retrospective cohort data, the
five-year survival following the diagnosis of metastases is 15%. It is not
clear if this 15% survival is achieved by earlier detection as no studies have
yet to confirm the survival benefit of intense surveillance in STS.
Regular, intensive surveillance is more likely to identify recurrent disease
earlier than would less intensive surveillance. However, the adverse effects of
intensive surveillance practices are also noteworthy. The costs that healthcare
systems incur as a result of sarcoma surveillance are substantial. Furthermore,
intensive surveillance can threaten the financial security of patients, due in
part to the direct (including travel, accommodation, personal care and
homemaking) and indirect costs (including lost wages for patients and their
caregivers) incurred as a result of follow-up appointments. As a result,
patients* health and quality of life can be dramatically impacted
Study objective
Does the frequency and mode of surveillance affect patient survival following
extremity STS surgery?
Study design
The SAFETY trial is a multi-center 2X2 factorial RCT of participants with
extremity STS who present without metastases and who require surgical
management and post-operative surveillance for local and systemic disease
recurrence with a total follow-up of 5 year.
Intervention
Participants will be randomized to one of four treatment / surveillance groups:
1) Clinical assessment and CXR every three months for two years;
2) Clinical assessment and CXR every six months for two years;
3) Clinical assessment and Chest CT every three months for two years; or
4) Clinical assessment and Chest CT every six months for two years.
Study burden and risks
The burden and risks associated with participation differ little from standard
care.
Depeding on randomisation patients surveillance will be 3 monthly for the fosrt
2 years or 6 mornthly for the forst 2 years. Depending on randomisatien patient
will have a chest X-ray of CT scan of the chest. This implies radiation,
however, these additional exams are also embedded in the current standard of
care.
At baseline and at follow-up questionnaires will be completed. Some questions
are of personal nature and can be perceived as uncomfortable.
Participation in this trial does not change the risk of recurrence of sarcoma
or development of distant metastatis.
Concession street 711
Hamilton ON L8V 1C3
CA
Concession street 711
Hamilton ON L8V 1C3
CA
Listed location countries
Age
Inclusion criteria
Patients who satisfy all of the eligibility criteria outlined below are to be
included in the SAFETY trial:
1) The patient is 18 years of age or older;
2) The patient has been diagnosed with a primary extremity grade II or III STS;
3) The patient has undergone surgical excision of the tumor with curative
intent and with no evidence of gross residual disease based on the pathology
report;
4) The patient has completed all planned neoadjuvant or adjuvant radiation and
/ or chemotherapy, if applicable;
5) The tumor size is greater than or equal to five centimeters according to the
pathology report or based on the pre-treatment MRI if neoadjuvant radiation and
/ or chemotherapy are given
Exclusion criteria
Patients who meet any of the following criteria are not to be included in the
SAFETY trial:
1) The patient has metastases at initial presentation based on the radiology
report of the initial thoracic imaging;
2) The patient has recently undergone surgical excision of a local recurrence;
3) The patient has been diagnosed with one of the special sub-types, myxoid /
round cell liposarcoma or extra-skeletal Ewing*s sarcoma;
4) The patient has been previously diagnosed with a genetic syndrome with an
elevated risk of malignancy, such as Li-Freumeni Syndrome*;
5) The patient has been previously diagnosed with a co-morbid condition that
has a life expectancy of less than one year;
6) The site-specific surveillance protocol for the patient*s disease is not
compatible with the study protocol (i.e., regular planned whole-body imaging
with positron emission tomography [PET] scans);
7) Likely problems, in the judgment of the investigator, with the patient
maintaining follow-up (with the specific reasoning requiring approval of the
Methods Center);
8) The patient is currently enrolled in a study that does not permit
co-enrolment
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03944798 |
| CCMO | NL76116.058.20 |